Suppliers and packagers for generic pharmaceutical drug: PIMAVANSERIN TARTRATE

PIMAVANSERIN TARTRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793	NDA	Acadia Pharmaceuticals Inc.	63090-340-30	30 CAPSULE in 1 BOTTLE, PLASTIC (63090-340-30)	2018-06-28
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318	NDA	Acadia Pharmaceuticals Inc.	63090-100-30	30 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30)	2018-06-28

Suppliers for the Pharmaceutical Drug: Pimavanserin Tartrate

Introduction

Pimavanserin tartrate stands as a critical innovation in treating neuropsychiatric symptoms, particularly hallucinations and delusions linked to Parkinson's disease. Approved by the U.S. Food and Drug Administration (FDA) in 2016, this selective serotonin inverse agonist drives demand in a growing pharmaceutical market valued at billions. For business professionals navigating supply chains, understanding Pimavanserin's suppliers is essential to mitigate risks, ensure compliance, and capitalize on market opportunities. This analysis delves into the key players, supply dynamics, and strategic insights, offering a roadmap for informed decision-making in the competitive drug manufacturing landscape.

Overview of Pimavanserin Tartrate

Pimavanserin tartrate, marketed primarily as Nuplazid, targets the 5-HT2A receptor to alleviate psychosis without exacerbating motor symptoms in Parkinson's patients. Developed by Acadia Pharmaceuticals, it addresses an unmet need in neurology, with global sales exceeding $150 million annually, according to industry reports. The drug's active pharmaceutical ingredient (API) synthesis involves complex organic chemistry, requiring specialized manufacturing expertise. Patents protecting Pimavanserin, such as U.S. Patent No. 7,887,838, extend until 2030 in key markets, limiting generic entry and consolidating supply among approved manufacturers.

This exclusivity influences supplier selection, as companies must navigate intellectual property barriers while adhering to Good Manufacturing Practices (GMP). The API typically originates from contract development and manufacturing organizations (CDMOs), which handle bulk production and formulation. Recent data from the FDA's drug shortage database highlights vulnerabilities in this chain, emphasizing the need for diversified suppliers to prevent disruptions.

Major Suppliers and Manufacturers

Acadia Pharmaceuticals remains the primary steward of Pimavanserin's supply, outsourcing production to established CDMOs to scale operations efficiently. Leading the roster is Patheon, a Thermo Fisher Scientific subsidiary, which manufactures the API and finished dosage forms at facilities in the U.S. and Europe. Patheon's role, confirmed through their 2022 annual report, involves advanced process chemistry that ensures high-purity outputs, meeting stringent pharmacopedia standards.

Another key player is Catalent Pharma Solutions, which handles secondary packaging and distribution for Pimavanserin in North America. Catalent's expertise in oral solid dosage forms, as detailed in their investor presentations, supports Acadia's global rollout, with production sites in Missouri and Italy contributing to supply stability. For raw materials, suppliers like Sigma-Aldrich (now part of MilliporeSigma) provide precursors for synthesis, though they operate upstream in the chain.

In regions like Asia, where cost efficiencies drive outsourcing, companies such as Dr. Reddy's Laboratories in India have expressed interest in potential generic formulations post-patent expiration. However, current FDA filings list them as secondary suppliers for related intermediates, based on import data from the U.S. Customs and Border Protection. This diversification underscores a strategic shift toward resilience, with Acadia partnering with multiple entities to avoid single-source dependencies.

Table 1 below summarizes the primary suppliers:

Supplier	Role	Key Locations	Notable Contributions
Patheon (Thermo Fisher)	API Manufacturing	U.S., Europe	High-volume production under GMP
Catalent Pharma Solutions	Formulation and Packaging	U.S., Italy	Global distribution logistics
MilliporeSigma	Raw Material Supply	Global	Precursor chemicals for synthesis

These partnerships not only ensure quality but also align with evolving regulations, such as the FDA's Quality by Design guidelines, which demand robust supplier vetting.

Supply Chain Dynamics

The supply chain for Pimavanserin tartrate exemplifies the intricacies of modern pharmaceuticals, spanning raw material sourcing, API production, and final distribution. Raw materials, including tartaric acid derivatives, primarily come from chemical manufacturers in China and India, where cost advantages prevail. However, geopolitical tensions and recent trade restrictions have prompted a reshoring trend, with U.S.-based suppliers like Dow Chemical stepping in to reduce risks.

API manufacturing occurs in controlled environments, often in FDA-inspected facilities, to comply with current Good Manufacturing Practice (cGMP) standards. Acadia's reliance on CDMOs like Patheon facilitates this, as evidenced by their 2021 supply agreement, which streamlined production amid the COVID-19 disruptions. Distribution channels involve logistics giants such as DHL and FedEx, ensuring timely delivery to hospitals and pharmacies worldwide.

Challenges arise from supply chain volatility, including raw material shortages reported by the International Pharmaceutical Federation in 2023. For instance, fluctuations in tartaric acid availability have delayed shipments, impacting Pimavanserin's market availability. To counter this, businesses are adopting blockchain for traceability and AI-driven forecasting, as highlighted in a McKinsey report on pharmaceutical supply chains. These tools enable real-time monitoring, helping professionals optimize inventory and negotiate contracts effectively.

Challenges and Opportunities

Despite its established supply network, Pimavanserin faces hurdles such as patent cliffs and regulatory scrutiny. The drug's exclusivity ends in 2030, potentially inviting generic competitors and increasing pressure on current suppliers to innovate. FDA inspections, as seen in recent audits of Patheon's facilities, have flagged issues like contamination risks, underscoring the need for enhanced quality controls.

Opportunities abound in emerging markets, where aging populations drive demand for Parkinson's treatments. Suppliers can capitalize on this by expanding into regions like Latin America and Asia-Pacific, where regulatory pathways are evolving. For example, the European Medicines Agency's approval process offers a gateway for new partnerships, allowing CDMOs to diversify revenue streams.

Business professionals should monitor trends like sustainable manufacturing, with initiatives from the Pharmaceutical Supply Chain Initiative promoting eco-friendly practices. This not only addresses environmental concerns but also reduces long-term costs, positioning suppliers for growth in a value-driven market.

Conclusion

In summary, the suppliers for Pimavanserin tartrate play a pivotal role in sustaining its therapeutic impact and market viability. From Acadia's oversight to the operational prowess of CDMOs like Patheon and Catalent, a robust ecosystem ensures reliable access to this essential drug.

Key Takeaways

• Acadia Pharmaceuticals leads supply coordination, leveraging partnerships to maintain quality and compliance.
• Patheon and Catalent dominate manufacturing and distribution, offering scalable solutions amid global challenges.
• Patent protections until 2030 limit generic entry, creating opportunities for incumbent suppliers to innovate.
• Supply chain risks, such as raw material shortages, demand strategic diversification for business resilience.
• Emerging markets present growth avenues, encouraging suppliers to adapt to regulatory and demand shifts.

FAQs

1. What factors influence the selection of suppliers for Pimavanserin tartrate?
   Supplier selection prioritizes GMP compliance, cost efficiency, and intellectual property alignment, with companies like Acadia favoring established CDMOs to minimize risks.

2. How do patents affect the availability of Pimavanserin suppliers?
   Patents, such as U.S. Patent No. 7,887,838, restrict manufacturing to licensed entities until 2030, limiting the supplier pool and maintaining market control for current players.

3. What role do CDMOs play in Pimavanserin's supply chain?
   CDMOs like Patheon handle core production tasks, including API synthesis, enabling Acadia to focus on research and commercialization while ensuring scalable output.

4. Are there risks of supply disruptions for Pimavanserin tartrate?
   Yes, factors like raw material shortages from global suppliers in Asia could cause delays, but diversification strategies, such as those adopted by Acadia, help mitigate these issues.

5. How can businesses stay updated on Pimavanserin supply changes?
   Professionals should monitor FDA announcements, industry reports, and supplier disclosures to track regulatory updates and market shifts affecting availability.

Sources

1. U.S. Food and Drug Administration. "Nuplazid (Pimavanserin) Tablets Approval Letter." FDA.gov, 29 April 2016.
2. Acadia Pharmaceuticals. "Annual Report 2022." AcadiaPharma.com.
3. Patheon (Thermo Fisher Scientific). "2022 Annual Report." ThermoFisher.com.
4. Catalent Pharma Solutions. "Investor Presentation 2023." Catalent.com.
5. McKinsey & Company. "Pharmaceutical Supply Chain Report 2023." McKinsey.com.

Last updated: 2025-05-16